Effect of L-Thyroxine on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism

September 11, 2018 updated by: Ling Gao, Shandong Provincial Hospital

The Beneficial Effect of L-Thyroxine Long -Term Replacement on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism: A Prospective Study

Subclinical hypothyroidism (SCH) is a common condition affecting 3-10% of the general population, especially in women older than 50 years old. It is controversial whether SCH can lead to increased risks of cardiovascular (CV) disease and whether treatment with L-thyroxine reverses these risks. The present study was designed to evaluate the effect of L-thyroxine treatment in SCH on lipid profile, atherosclerosis, endothelial function, serum inflammatory factors and adipocytokines.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250021
        • Shandong Provincial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female aged of 18 to 60 years old;
  • Diagnosis was subclinical hypothyroidism(elevated serum thyroid-stimulating hormone levels with normal serum free T4 levels measured at least two times with a three-month interval);
  • untreated.

Exclusion Criteria:

  • Pregnancy or lactation women;
  • Presence of pituitary/hypothalamic disorders, diabetes mellitus or other endocrinal and metabolic disorders;
  • Presence of psychological or physical disabilities,acute infection, cerebrovascular or cardiovascular disease, chronic respiratory disease and other illnesses known to alter lipid metabolism;
  • Taking lipid-lowering agents and other drugs that known to influence thyroid function, blood pressure, heart function or bile acids;
  • Obviously poor compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: L-thyroxine
Oral administration, starting dose 25 or 50 micrograms once daily.
Drug: L-thyroxine
NO_INTERVENTION: blank
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in lipid profile
Time Frame: measured at baseline; 6 month; 12 months and 24 months.
measured at baseline; 6 month; 12 months and 24 months.
change in thickness of blood vessel wall
Time Frame: measured at baseline; 6 months; 12 months and 24 months.
measured at baseline; 6 months; 12 months and 24 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
change in endothelial function
Time Frame: measured at baseline; 6 months; 12 months and 24 months.
measured at baseline; 6 months; 12 months and 24 months.
change of adipocytokines
Time Frame: measured at baseline; 6 months; 12 months and 24 months.
measured at baseline; 6 months; 12 months and 24 months.
Change of Oxidative Stress and Chronic Inflammatory Factors Related with Atherosclerosis
Time Frame: measured at baseline; 6 months; 12 months and 24 months.
measured at baseline; 6 months; 12 months and 24 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong Provincial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ANTICIPATED)

April 1, 2022

Study Completion (ANTICIPATED)

April 1, 2022

Study Registration Dates

First Submitted

April 7, 2013

First Submitted That Met QC Criteria

April 10, 2013

First Posted (ESTIMATE)

April 15, 2013

Study Record Updates

Last Update Posted (ACTUAL)

September 12, 2018

Last Update Submitted That Met QC Criteria

September 11, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012GSF11824

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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